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The FDA has accepted Chelsea Therapeutics' application to market Northera, or droxidopa, as a treatment for symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure, non-diabetic autonomic neuropathy and dopamine beta hydroxylase deficiency. "We will continue to work closely with the FDA toward an approval decision for Northera by early next year, and advance our commercial strategy in anticipation of a U.S. commercial launch soon after this," Chelsea's interim CEO, Joseph Oliveto, said.

Related Summaries

H. Lundbeck said it plans to purchase Chelsea Therapeutics for as much as $658 million. The acquisition, expected to be finalized next quarter, will give Lundbeck access to Chelsea's investigational neurologic disorder treatments and its FDA-approved neurogenic orthostatic hypotension drug Northera. The firms expect Northera to enter the market in the second half of 2014.

Chelsea Therapeutics obtained federal approval for its Northera drug to address neurogenic orthostatic hypotension related to Parkinson's disease, multiple-system atrophy and pure autonomic failure. It is one of two drugs approved for NOH.

An FDA advisory panel endorsed the approval of Chelsea Therapeutics International's Northera, or droxidopa, as a treatment for neurogenic orthostatic hypotension. Many of the panelists, however, recommended that Chelsea conduct an additional study to prove the long-term efficacy of the drug.

An FDA advisory panel agreed to review Chelsea Therapeutics' new drug application for Northera, or droxidopa, as a treatment for symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure. Northera was previously granted orphan drug and fast track designations by the FDA. A decision is expected by mid-February.

Chelsea Therapeutics International secured a U.S. patent that extends until 2026 its marketing exclusivity for Northera, a hypotension drug. The patent allows the drugmaker to pursue other uses for the treatment.